Clinical Research Program

What do I need to do while running a study?

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Maintain
study data

Information:

As you gather information from your study subjects it is key that you maintain data per study requirements.

Your study’s data collection Standard Operating Procedure (SOP) should delineate data-based duties -- such as data entry and query resolution timelines – and designate who on your team will be responsible for these tasks. Make sure to include these duties in your Delegation of Responsibilities Log.

Remember the difference between Source Documents (wherever participant information is first recorded) and Case Report Forms (CRFs – the forms were study data is reported) and utilize these data sources appropriately.

If you are not supplied with CRFs by your study sponsor, it is important that you work with your team to design CRFs that will capture the data required for your study.

Working with paper vs. electronic CRFs (eCRFs) can require different procedures. Make sure that you are clear how your study is going to be collecting data and follow all procedures per protocol.

All clinical research data should be entered into a data base in a timely manner and should be checked for Quality Assurance (QA) on a regular basis. See the Partners QI Program’s Monitoring Plan template for guidance. Make sure that someone on your team has been delegated the responsibility of performing QA procedures for your study and that these procedures are detailed in your study’s SOPs.

Study databases that contain participant identifiers must be maintained behind the Partners firewall and should be saved to a study-specific shared drive that is backed-up on a regular basis. Be aware that you are required to follow Partners encryption rules on all computers and drives being used for your project.

Besides helping to manage data appropriately, the data entry and QA process can to help you monitor Unanticipated Problems and Adverse Events (AEs) within your project. The Adverse Events Tracking Log is the tool to use to document AEs for your project.